Validation Associate
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Job no.: 494828
Work type: Full Time Permanent
• Responsible for crafting, maintaining and continually improving the validation system (in conjunction with the Quality Manager) in line with current national and international standards.
• Responsible for implementation and ongoing improvement of validation policies and procedures within the company Quality Management System, along with providing technical expertise within those functional areas}
• Join an ASX listed company.
About us:
DoseAid is a leading supplier of dose administration aid products to community pharmacies, aged care facilities and hospitals throughout Australia.
DoseAid is a subsidiary of the EBOS Group. With almost 5,000 employees in 109 locations across Australia, New Zealand, and Southeast Asia, EBOS Group is the largest and most diversified Australasian marketer, wholesaler and distributor of healthcare, medical and pharmaceutical products. It is also a leading marketer and distributor of recognised animal care brands.
EBOS Group is publicly listed on the New Zealand and Australian stock exchanges.
The Opportunity:
The Validation Associate will be responsible for creating and executing validation processes for all existing and new equipment, ensuring the processes are in line with best practice and evolving regulatory expectations.
What you will do:
Manage our validation and requalification programs, examining current validation processes and recommending improvements.
Responsible for implementation and ongoing improvement of validation policies and procedures within the company Quality Management System, along with providing technical expertise within those functional areas.
Responsible for oversight and execution of validations for production, manufacturing and cleaning processes.
Develop/review and approve validation protocols and final reports and ensure compliance with cGMP and current regulatory requirements.
Define, support and guide validation activities.
Responsible for ensuring validation studies of the operations and quality control facilities, the utilities serving the facilities, and manufacturing/operations areas, and testing equipment are completed to the required cGMP standards.
Review change requests for impact to validation and support QA compliance activities such as Product Quality Review.
Maintain Revalidation Plan and all manufacturing, while ensuring all revalidation is performed and reported.
Prepare and maintain Validation Master Plans for the facility, utility, and equipment to ensure they are all adequately validated for cGMP projects undertaken within the facility.
What we are looking for:
Tertiary qualifications in Science, Engineering, or related discipline
Thorough knowledge and understanding of validation requirements in a cGMP facility and Validation Lifecycle Approach.
Experience in process validation execution and Equipment Qualification.
Preferred experience in cleaning validation, utilities qualification and computerised systems validation
Competent in statistical analysis techniques required to understand process performance, sampling strategies, and quality acceptance standards.
Why us?
This is a unique opportunity to work in a company where you are valued, given the recognition you deserve and suitably rewarded for your hard work.
Other benefits include:
Employee Share Plan
Company Paid Parental Leave
Employee Assistance Program for Mental Health Wellbeing
Staff Awards
Employee Referral Program
Health Insurance Discounts
Working in our state-of-the-art, purpose-built facility, built to GMP standards.
Flexible working options including hybrid working model and flexible start and finish times (within reason)
We are committed to fostering a workplace that values diversity and inclusion. As an equal opportunity employer, we actively strive to build a gender-equitable team and cultivate a culture that embraces individuals from all walks of life. We welcome applications from candidates of diverse backgrounds, abilities, ages, and cultures (including First Nations Peoples).
Our commitment to inclusivity extends to supporting candidates with disabilities throughout the recruitment process. If you require any accommodations due to disability, please inform us by reaching out to HR@ebosgroup.com . We believe that a diverse and inclusive workforce enriches our organisation and contributes to our success.
Pre-employment checks may be required and will be discussed with the successful candidate.
If you believe that you have the necessary attributes to succeed in this challenging and rewarding role, please apply by click “Apply”.
No agency assistance will be required.
Advertised: 13/12/2024 E. Australia Standard Time
Applications close: 10/01/2025 E. Australia Standard Time
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